BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER

    MDR report key: 3021230 · Received March 21, 2013

    Report

    Report Number
    3021230
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 19, 2013
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    DURING THE ROBOTIC PROCEDURE, THE SURGEON WANTED TO USE THE VESSEL SEALER. THE TECH LOADED THE VESSEL SEALER INTO ARM 1 OF THE PATIENT CART OF THE ROBOT. IT WAS WITNESSED THAT THE VESSEL SEALER WILL BURN OUT AND CUT ON THE FIRST TRY, AFTERWARDS THE SURGEON TRIED TO USE IT AGAIN AND IT WAS WITNESSED THAT THE VESSEL SEALER WOULD BURN ONLY. ANOTHER DEVICE WAS NEEDED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117655 ENDOWRIST ONE VESSEL SEALER SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. * S10121219

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR